Cause of Device-Related Incident
Device factors

Clinical Specialty or Hospital Department
Cardiology / Cardiac Catheterization; Clinical/Biomedical Engineering; Medical Records; Nursing; Obstetrics and Gynecology

Device Factors
Design / labeling error; Failure of accessory

Document Type
User Experience Network (UEN) reports

External Factors
Environmental (temperature, humidity, light)

Mechanism of Injury or Death
Misdiagnosis

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
*Not stated

UMDNS
ECG Monitors [12-599]; Paper, Recording [15-639]; Paper, Recording, ECG [16-754]; Sphygmomanometers, Electronic [16-157]

Fading Images on Thermal Paper



User Experience Network™ [Health Devices Oct 1990;19(10):374-5]

We have received several reports of fading images on thermal paper used with the thermal printers in electronic sphygmomanometers and ECG monitors. Although the initial images were good, they faded after a few months in storage. Because patient records are usually kept for years, loss of diagnostic traces can create medical and legal difficulties.

Basic thermal paper, a layered composite of base paper, thermal coating, and protective coating, is produced by several manufacturers and is subsequently reprocessed by many different suppliers for use in various recording devices. Reprocessing includes adding artwork, cutting and trimming, rolling or folding, perforating, or otherwise reworking the basic paper. Although most paper manufacturers rigorously test their thermal papers and expect them to preserve an image for at least five years, poor reprocessing techniques can alter the paper's characteristics, thereby reducing its image life.

Images are produced when a small area of the paper is heated, creating a chemical reaction that causes a color change in the paper's thermal coating. The performance characteristics (e.g., image quality, effect on thermal printer, image life) of paper from different manufacturers or from different lots can vary because of the variety and combination of binders, dye precursors, color formers, artwork inks, paper fillers, and protective coatings. The specific materials used to make thermal papers are proprietary.

Other factors that affect the paper's image life include environmental effects and the paper's sensitivity to temperature, humidity, and light. Also, the organic chemicals used in the coatings react to a number of solvents and plastics found in hospitals. Some manufacturers and suppliers provide warnings about these hazards, common to all thermal papers; however, these warnings are not always obvious or well known to users or to personnel in the medical records department.

The recording device or printer manufacturer, or a reliable after-market supplier, typically matches thermal papers and devices or printers to achieve the best image quality and produce the least effect on the printer. Using untested paper with an unmatched thermal printer can cause poor image quality and damage the printer.

Recommendations

  1. For the best image quality and thermal printer life, choose a paper specifically recommended by the recording device manufacturer for use in the printer. Most device manufacturers can recommend several brands of thermal paper that work well with the printers in their equipment. Another safe choice is to purchase paper offered by after-market suppliers who will warrant the paper and printer against damage from the use of their product.
  2. Photocopy any especially critical printed thermal paper records that must be kept for longer than six months. Plain bond photocopies last far longer than thermal paper. Keep the original record and the photocopy; these can be compared to gauge image life and to assess any alterations, other than fading, that may have occurred to the original document.
  3. Keep thermal paper away from organic liquids and vapors (e.g., alcohol, solvents, plasticizers, petroleum products) that cause the image to fade or the thermal coating to discolor. Careless cleaning of thermal printers, storing thermal paper with carbon or carbonless paper, contacting thermal paper with adhesive tape or prep pads, or storing different grades of thermal paper together are a few practices that can cause organic materials to damage thermal paper and images.
  4. Store unused thermal paper in its original container in cool, dry, dark places to preserve its chemical and physical characteristics. Excessive heat, moisture, or light can alter the quality of the thermal paper. Normal office conditions (72° F, 45% RH) are best.
  5. To preserve the image, store printed thermal paper in manila folders or envelopes away from plastic folders, binders, or boxes. Also protect printed paper from excessive heat, humidity, and light.
  6. For further information, contact your printer manufacturer or paper supplier. If you have difficulty obtaining information, try to contact one of the larger thermal paper manufacturers.

UMDNS Terms

  • ECG Monitors [12-599]
  • Paper, Recording [15-639]
  • Paper, Recording, ECG [16-754]
  • Sphygmomanometers, Electronic [16-157]
  • Cause of Device-Related Incident

    Device factors: Design/labeling error; Failure of accessory

    External factor: Environmental

    Mechanism of Injury or Death

    Misdiagnosis


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